The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neuro
FDA device recall Z-0980-2025 · posted 2025-01-17 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- Reason for recall
- There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
- Action taken
- Stryker issued a Medical Device Recall notice to its consignees on 06/28/2024 via FedEx. The notice explained the issue and requested the following actions be taken: "1. Review your inventory to locate and quarantine any affected products found on-hand. 2. Sign and return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email Instruments.recalls@stryker.com. 3. Upon receiving your Business Reply Form to the email, Instruments.recalls@stryker.com, a shipping label will be provided to return any recalled product on-hand. 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Jordan Anderson at (269) 800-1347 or Instruments.recalls@stryker.com with questions or concerns."
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HBE
- Quantity affected
- 491 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
- Date initiated
- 2023-06-28
- Date posted
- 2025-01-17
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K143320) | Stryker Corp. | 2015-04-23 |